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Instructions for Use
H110
DESCRIPTION:
Hummingbird Parenchymal IntraCranial
Pressure Monitoring Catheter Kit
KIT CONTENTS:
1 Bolted Parenchymal ICP Catheter Kit:
- Parenchymal ICP Monitoring
Catheter
- Bolt with Dilator
- Drill Bit with Collar and Hex
Wrench
1 Skull Thickness Caliper
1 Stab Incision Knife
P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved
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Summary of Contents for Hummingbird H110
- Page 1 Instructions for Use H110 DESCRIPTION: Hummingbird Parenchymal IntraCranial Pressure Monitoring Catheter Kit KIT CONTENTS: 1 Bolted Parenchymal ICP Catheter Kit: - Parenchymal ICP Monitoring Catheter - Bolt with Dilator - Drill Bit with Collar and Hex Wrench 1 Skull Thickness Caliper 1 Stab Incision Knife P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19;...
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Page 2: Table Of Contents
Step 8b - Insertion of the Catheter into the Bolt ............... 11 Step 9 – Access Completed, Zeroing the ICP Monitoring System and Connecting the Catheter ............................11 MAINTENANCE OF THE H110 AND BOLT INSERTION SITE ............. 13 ICP Lumen Connector Maintenance: ..................13 CATHETER REMOVAL PROCEDURE....................13 Step 1 –... -
Page 3: List Of Symbols And Terminology
IST OF YMBOLS AND ERMINOLOGY List of Symbols Symbol Meaning Manufacturer Refer to the Instructions for Use Expiration Date expressed as year-month-day (yyyy-mm-dd). Non-Pyrogenic Do not reuse after opening Model number Lot Number Sterile unless package is open. Method of sterilization – ethylene oxide. Temperature limits Relative humidity limits Keep dry... -
Page 4: System Overview
ICP pressure. Refer to the HICP200 Quick Reference Guide and Instructions For Use (IFU) for operating instructions. The Patient Cable Module requires no leveling and can be zeroed in-situ. The H110 is packaged in a kit that kit consists of the following items: •... -
Page 5: Contraindications
For single-use only—Do not reuse. If opened and unused, discard immediately. The H110 has not been designed to undergo or withstand any form of alteration, such as disassembly, cleaning or re-sterilization, after a single patient use. These devices are... - Page 6 H110 OMPONENTS OF THE Depth Limiting Collar P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved...
- Page 7 H110 I NSERTION ROCEDURE UMMARY IGURES P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved...
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Page 8: Procedure Preparation
Connect the HICP200 to the patient monitor a minimum 15 minutes before beginning the procedure to allow the transducer to rise to an equilibrium temperature. • Open the H110 kit using aseptic technique. Step 1 – Estimate Skull Thickness and Prepare the Access Site •... -
Page 9: Step 3 - Irrigate The Twist Drill Hole
Failure to properly incise the dura could cause the catheter’s pressure-sensing bladder tear during insertion of the H110 and performance to be compromised. P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved... -
Page 10: Step 5 - Measure Skull Thickness
Step 5 – Measure Skull Thickness Refer to the Skull Thickness Caliper Quick Guide section of this IFU to. Measure the skull thickness. Step 6 - Fixation of Bolt • Position the Bolt in the drill hole. • To advance the Bolt, screw the Bolt clockwise in skull to the depth of the measured skull thickness. -
Page 11: Step 8A - Aligning The Catheter To The Bolt
Step 8a – Aligning the Catheter to the Bolt • Holding the catheter by the blue insert, align the insert’s ribs to the Bolt’s slot (it can fit in one of two positions). Step 8b - Insertion of the Catheter into the Bolt •... - Page 12 The HICP200 Control Module, Monitor Cable, Patient Cable Module and AC Adaptor are MR-unsafe and must not enter the MRI field. P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved...
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Page 13: Maintenance Of The H110 And Bolt Insertion Site
NSERTION In general, there is a risk of infection due to use of intracranial catheters. It is recommended that the H110 not be left in place for more than 5 days. ICP Lumen Connector Maintenance: Before cleaning the surface of the ICP Lumen Connector, note the following: •... -
Page 14: Step 4 - Close Surgical Site
Step 4 – Close surgical site • Close cranial access site per standard hospital procedure. Step 5 – Cleaning and care of the HICP200 and its components. • Reference the HICP200 IFU (a summary is provided below). HICP200 AINTENANCE AND ARE OF THE It is recommended that the Control Module and its components be cleaned as soon as is reasonably practical after use. -
Page 15: Contacting Technical Support
Disconnect the ICP catheter from the Patient Cable Module prior to zeroing the patient monitor, as failure to do so may result in pressure offset and inaccuracy. The Patient Cable Module must communicate with atmospheric pressure when zeroing the patient monitor. Confirm that the HICP200 is powered on by checking the indicator lights. - Page 16 NOTE: ±2 mmHg from 0-20 mmHg and ±10% from 20 to 100 mmHg (per ANSI / AAMI NS28) To maintain accuracy, re-prime is required if the Hummingbird ICP is Time of Use (for exposed to a 10 °C (or greater) or 25%RH (or greater) change.
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Page 17: Mr Conditional Information
MR C ONDITIONAL NFORMATION Non-clinical testing has demonstrated the bolt and catheter is MR-Conditional. A patient with this device can be scanned safely in an MR system under the following conditions: • Static magnetic field of 1.5 Tesla and 3 Tesla, only •... -
Page 18: Skull Thickness Caliper Quick Guide
KULL HICKNESS ALIPER UICK UIDE P/N: 7000608 Rev B CO-260 Released Date: 2021-01-19; ©2021, IRRAS USA, Inc. All rights reserved... -
Page 19: Warnings
If there are additional questions after reading this IFU, contact IRRAS USA, Inc.. The H110 has not been designed to undergo or withstand any form of alteration, such as disassembly, cleaning or re-sterilization, after a single patient use. These devices are... -
Page 20: Cautions
In general, there is a risk of infection due to use of intracranial catheters. It is recommended that the H110 not be left in place for more than 5 days. Do not autoclave, use automated cleaning methods, or immerse the Control Module in liquid as damage may occur. -
Page 21: Return Goods Policy
CAUTION: Federal law restricts this device to sale by or on the order of a physician (licensed healthcare practitioner). Do not use if the package has been opened or damaged. Hummingbird is a registered trademark of IRRAS USA, Inc. Manufactured under one or more U.S. patents Nos. 10,687,720 and 6,673,022 and 7,780,679; other U.S.
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